Tuskegee University Division of Research and Sponsored Programs

Office of Grantsmanship and Compliance

Animal Care and Use Committee

Operational Procedures and Policies Guide

for the Care and Use of Animals

in Research and Teaching

ii

CONTENTS

Preface .............................................................................................................................................iv

Responsibilities When Using Vertebrate Animals in Research, Teaching, or Testing

1. Introduction .........................................................................................................................1

2. Definitions ...........................................................................................................................1

3. Approval for Use of Animals in Research, Teaching, and Testing .....................................1

4. Student Research .................................................................................................................2

5. The Review Process for Animal Use Approval ..................................................................2

6. Relevant Training and Experience ......................................................................................2

7. Supervision of Personnel and Students ...............................................................................2

8. Deviations from Approved Protocols ..................................................................................3

9. Animal Facility Maintenance for Research .........................................................................3

10. Acquisition of Animals .......................................................................................................3

11. Policy on Sick Animals Housed in the Animal Facilities ...................................................4

12. Records Keeping for Animals Used in Research, Teaching, and Testing ...........................4

13. Health and Safety Considerations .......................................................................................4

14. Who is at Risk .....................................................................................................................4

Tuskegee University Animal Care and Use Committee Policy and Procedures

15. Animal Care and Use Committee Policy and Procedures ...................................................5

16. Public Health Service Policy ...............................................................................................5

17. Guide for the Care and Use of Laboratory Animals............................................................5

18. 2000 Report Veterinary Medical Association Panel on Euthanasia ....................................5

19. Animal Welfare Regulations (AWR) ..................................................................................6

20. Tuskegee University Animal Care and Use Committee (TUACUC) .................................6

21. Responsibilities of the TUACUC

1. Semiannual Reviews of Tuskegee University’s Animal Care Program ..........................7

2. Semiannual Reports to the Provost..................................................................................7

3. Reports to the Office of Laboratory Animal Welfare (OLAW) ......................................7

4. Reports to U.S. Department of Agriculture (USDA) and Animal and Plant

Health Inspection Service (APHIS) .............................................................................7

5. Review of Animal Care and Use Application Form........................................................8

6. Monitoring and Possible Suspension of Ongoing Activities ...........................................8

7. Responding to Public Concerns ......................................................................................9

8. Records Keeping .............................................................................................................9

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Appendix A: Animal Care and Use Protocol Form................................................... 10-18

Appendix B: Terms for Approval or Disapproval of Application Form.........................19

Appendix C: Reference Materials ...................................................................................20

Appendix D: List of Approved Sources for Animal Purchase ........................................21

Appendix E: Pain and Distress Classifications ......................................................... 22-23

Appendix F: Animal Subject Transfer or Census Change Form ....................................24

Appendix G: Occupational Health for Animal Care Personnel................................. 25-27

Documentation Form for Animal Care Personnel Occupational

Health Program ..........................................................................................28

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PREFACE

The revised second edition of the Operational Procedures and Policies Guide for the Care

and Use of Animals in Research or Teaching is designed to further the University’s goal

in teaching; testing and demonstration through the use of animals which must follow

humane and scientifically appropriate procedures. This guide will support such efforts at

Tuskegee University. The primary purpose of the document is to provide guidance to

Tuskegee University investigators, on how to plan for and conduct animal experiments

with the highest scientific and ethical principles that are humanly possible. The guide

provides information regarding the University’s Policies and Tuskegee University

Animal Care and Use Committee’s (TUACUC) policies and procedures to conduct

research on animals.

In research fields today, technological advances occur daily. For this reason, this guide

has been constructed in a manner which allows for the revision of any section without the

need to re-write the entire guide. Continuous revision is essential. Researchers’

suggestions for improvement are requested and appreciated. Please submit suggestions by

e-mail to Felecia Moss-Grant fmgrant@tuskegee.edu Office of Grantsmanship and

Compliance, Dr. Kunwar Srivastava srivastava@tuskegee.edu Veterinary Medicine,

Department of Pathobiology or Dr. Pochana Reddy reddyg@tuskegee.edu Veterinary

Medicine, Department of Pathobiology

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ACKNOWLEDGEMENTS

We would like to acknowledge William Watson, DVM and Mr. Frank Jaminson, for their

support, valued insight, and commitment throughout the development of this guide. Tuskegee University Animal Care and Use Committee (TUACUC);

Dr. Gopal Reddy (Chairman)

Dr. Michelle Corley

Dr. Kunwar Srivastava (Attending Veterinarian)

Dr. Monica Frazier

Ms. Rosalyn Butler

Mr. Frank Jaminson (Community Member)

Ms. Felecia Moss-Grant (Ex-officio)

Administrative Assistant

Montheletha Mitchell – Telephone number: 334-727-8234

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RESPONSIBILITIES WHEN USING VERTEBRATE ANIMALS IN RESEARCH,

TEACHING OR TESTING

Introduction

All activities involving animals must be conducted in accordance with humane and

ethical principles as established by federal laws, regulations, and guidelines pertaining to

animal care and use. Tuskegee University has an Animal Welfare Assurance Number on

file from the Office of Laboratory Animal Welfare (OLAW), and therefore follows the

Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals.

The information and the animal use application form in this guide conform to the PHS

Policy and Animal Welfare Act (AWA) of the United States Department of Agriculture

(USDA).

Definitions

• Animal — any live vertebrate animal (mammals, birds, fish, reptiles, and amphibians).

• Activities — research, teaching, training, experimentation, demonstration and related

activities, whether in the laboratory or in the field.

• Principal Investigator — the faculty member or other investigator with primary

responsibility for the oversight of the research, teaching, training, experimentation,

observation and related activities.

Animals may not be acquired for use at Tuskegee University before approval is

received from Tuskegee University Animal Care and Use Committee (TUACUC)

Approval for Use of Animals in Research, Teaching, and Testing

To obtain approval from the TUACUC, an Application for Animal Care and Use Form

for the use of animals in teaching, research and testing must be completed. The

completed Application for Animal Care and Use Form (original and seven copies) should

be submitted to the Administrative Assistant (Mrs. M.B. Mitchell - 727-8234), Rm. 119,

Williams-Bowie Hall, Tuskegee University. Application should be submitted a minimum

of 21 working days prior to the committee’s regular meeting date (last Friday of each

month). Application received after that date may not be reviewed during that month. A

copy of this form is provided in Appendix A. The application form can also be obtained

through the website from the Office of Research and Sponsored Programs Grantsmanship

and Compliance or the College of Veterinary Medicine Nursing, and Allied Health.

If there are any questions about the application form, please call Mrs. M. B. Mitchell,

Administrative Assistant at 727-8234, or the TUACUC Chair. Dr. Gopal Reddy. After

TUACUC review of the application form, the principal investigator will be informed of

the results, within 7 working days.

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Student Research

Students may not be designated as the investigators for animal activities; only a faculty

member may serve as principal investigator. Students may serve as co-investigators on a

project. Students intending to conduct research, demonstrations, or testing with animals,

must involve a faculty member from the beginning stages of the research project.

The Review Process for Animal Use Approval

All applications are reviewed by the TUACUC at the regular meetings (the last Friday of

each month). Approval/disapproval categories are defined in Appendix B. The TUACUC

will not approve applications that have not received approval from: the Radiation Safety

Committee, Biohazard Committee or Human Participant Review Committee. It is the

responsibility of the principal investigator to acquire approva1 from the appropriate

committees and to obtain approval from TUACUC.

Relevant Training and Experience

Investigators and other individuals involved in animal care and use at Tuskegee

University will be required to become familiar with materials that are relevant and

appropriate to their animal involvement. For example, investigators may be expected to

be familiar with the Animal Welfare Regulations (AWR), the NIH Guide for the Care

and Use of Laboratory Animals (Guide), the P1 Policy and the current Report of the

AVM Panel on Euthanasia. Investigators must be able to demonstrate that they have had

the training and experience necessary to humanely conduct the proposed teaching,

demonstration, testing, or research activities.

In accordance with humane and ethical principles as established by federal laws,

regulations, and guidelines pertaining to animal care and use, all new investigators who

direct or conduct surgical procedures on rodents will be required to view the video,

Basics of Aseptic Surgery and Anesthesia in Rodents, and read relevant sections of

Recognition and Alleviation of Pain and Distress In Laboratory Animals. Mrs. M.B.

Mitchell can be contacted to view the video.

Instructional and reference materials are maintained in the Comparative Medicine

Resource Center. These materials may be borrowed by faculty, investigators and other

individuals involved in animal care and use. See Appendix C for a list of the available

materials. As a supplement to these materials, the TUACUC home page has extensive

links to Web resources on animal care and use. Direct training with regards to special

techniques will be provided by the TUACUC or attending veterinarian.

Supervision of Personnel and Students

In the event that individuals other than the principal investigator will be involved in the

care and use of animals, the principal investigator is required to make arrangements with

the attending veterinarian for the necessary training of these individuals. The principal

investigator is responsible for the conduct of personnel and student researchers.

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Deviations from Approved Protocols

Once a protocol is approved, no changes are permitted. Changes to the approved protocol

must be approved by TUACUC

Examples of changes that must be reported immediately are listed below.

• Additions, deletions, or modifications of animal procedures as outlined in the

original protocol.

• Personnel directly involved with animal care or use

• Species of animals

• Number of animals

• Anticipated levels of pain or distress

• Location of housing or use

• Surgical procedures

• Drug doses

• Method of euthanasia

• Disposal of remains

These changes/deviations in the protocol will be reviewed in the same way as a new

proposal.

Animal Facility Maintenance for Research

The following information should be clearly posted on the door of the research animal

facility:

1) a schedule describing the frequency in which all animal caging is charged.

2) a list of the names and telephone numbers of responsible emergency contact

persons.

3) the address and telephone number of the Attending Veterinarian and the

principal investigator.

Acquisition of Animals

Research Animals acquired for research should be purchased from reputable sources. The

current approved sources are listed in Appendix D. Other suppliers of mammals may be

suggested by researchers, but these will require pre-approval by the TUACUC.

If animals will be collected in the wild, die appropriate permits must be obtained. The

living conditions for any wild animals must be appropriate for the species. Please contact

the Comparative Medicine Resource Center or the Attending Veterinarian to ensure that

all appropriate permits have been obtained for the animals collected in the wild. Under no

circumstances any stray dog or cat is to be used in teaching, research, or testing activities.

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Policy on Sick Animals Housed in the Animal Facilities

If an unexpected illness occurs, the investigator or his/her staff should contact the

Attending Veterinarian for examination and consultation. Animals that are experiencing

pain and distress (see Appendix E) or that are moribund will be referred to the Attending

Veterinarian for a decision on euthanasia.

Record Keeping for Animals Used in Research, Teaching, and Testing

The Animal Welfare Regulations and the PHS Policy require that the species and

numbers of animals used at Tuskegee University be closely monitored. This is

accomplished by requiring investigators to fill out the Animal Subjects Transfer/Census

Change Form (Appendix F) and send it to the Office of Comparative Medicine Resource

Center, within three (3) days of the census change.

Individual research animals housed in the animal facilities should be appropriately

identified by using color leg bards, tattoos, or cage cards; the cards should include the

name of the principal investigator, date of arrival of animals, TUACUC protocol number

and, if applicable, the date(s) of any surgical procedures conducted on the animal.

Health and Safety Considerations

The TUACUC publishes an educational document on Occupational Health for Animal

Care Personnel (Appendix G). Any person who is placed “at risk” is required to read the

document, visit the Tuskegee University assigned Health provider, complete and sign the

documentation form and send it to Mrs. MB. Mitchell, Room 119, Williams-Bowie Hall,

School of Veterinary Medicine, Tuskegee University.

Who is “at risk”?

Risk is determined by the species of animal, the amount of contact or exposure to the

animals, the duties involved and the hazards potentially encountered while exposed to the

animals. For example, an individual who handles rats (chance of being bitten) or cleans

the rat cages (chance of air-borne disease or allergens) is at risk. An individual who is

observing bird behavior on campus or observing fish in a fish tank is not at risk from the

animals. Whether someone is “at risk’ must be determined on an individual basis. If you

are not sure whether an individual il1 be placed at risk, please discuss with the TUACUC

chair or the Attending Veterinarian.

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TUSKEGEE UNIVERSITY ANIMAL

CARE AND USE COMMITTEE POLICY AND PROCEDURES

The Tuskegee University policies and procedures for the care and use of animals are

based on federal laws, regulations, policies and guidelines as provided by federal

agencies and other professional associations. Tuskegee University is a registered research

facility with the United States Department of Agriculture. Tuskegee University has an

Animal Welfare Assurance Number filed with the Office of Laboratory Animal Welfare

(OLAW), and, therefore is required to follow the Animal Welfare Regulations and the

Public Health Service Policy on the Humane Care and Use of Laboratory Animals.

Copies of the documents mentioned are available at the College of Veterinary Medicine

Library, and the Office of Comparative Medicine Resource Center.

Public Health Service Policy

The Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory

Animals was promulgated to implement the Health, Research and Extension Act of 1985

(Public Law 99-158, November 20, 1985, Animals in Research’ The PES Policy is

administered by the Office of Laboratory Animal Welfare (OLAW) of the National

Institutes of Health (NIH). This policy is applicable to all PHS-conducted or supported

activities involving animals. Tuskegee University does conduct PHS-supported animal

activities and has an Assurance Number filed with OLAW.

The PHS Policy describes the requirements and responsibilities of the TUACUC in

overseeing animal care and use in research, teaching, and testing at Tuskegee University.

The Guide for the Care and Use of Laboratory Animals

The Guide was prepared by the Institute of Laboratory Animal Resources of the National

Research Council revised in 1996. The PHS Policy requires institutions to use the Guide

as a basis for developing and implementing an institutional program for activities

involving animals. The Guide addresses several areas of concern that arise in animal

research, including the role of the TUACUC in monitoring the care and use of animals,

the use of physical restraint, surgical procedures, food or fluid restriction, occupational

health and safety of animal care personnel, housing of animals and veterinary medical

care.

2000 Report of the American Veterinary Medical Association (AVISIA) Panel on

Euthanasia

The PHS Policy states that methods of euthanasia will be consistent with the

recommendations of this panel. The report was published in the Journal of the American

Veterinary Medical Association, March 1, 2000 (Vol. 281, No. 5). For more information

on the AVISIA, go to the Office of Grantsmanship and Compliance website.

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The Animal Welfare Regulations (AWR)

The AWR are the principal federal rules governing the sale, purchases, handling,

transport and use of animals

(The Animal Welfare Act) The U. S. Department of Agriculture (USDA) Animal and

Plant Health Inspection Service (APHIS)/Animal Care (AC) implements the AWR.

Tuskegee University has USDA regulated animal activities and is a Registered Research

Facility. For more information on the AWR, go to the Office of Grantsmanship and

Compliance Website.

The Tuskegee University Animal Care and Use Committee (TUACUC)

1. The TUACUC charge is to implement federal guidelines as required by law concerning

animal care and use.

2. The Provost who appoints all committee members including the Chair is the

Institutional Official for Tuskegee University.

3. Membership

a. One doctor of veterinary medicine knowledgeable in laboratory animal

medicine.

b. Three members who have had experience in research involving animals.

c. One member whose primary concerns are in a non-scientific area.

d. One individual who is not affiliated with the University in any way other than

as a member of the TUACUC, and is not a member of the immediate family

of a person who is affiliated with the University. (Note: c and d may be one

individual)

e. The Chair will be appointed by the Provost from the three faculty members

with animal research experience.

f. Member replacement: A member who is unable to attend regular meetings up to

six times or complete his/her term may be replaced by the Provost

(Institutional Official) in order to maintain the committee membership.

4. Meeting schedule: Monthly, the last Friday of the month.

5. Reports to: Provost, Institutional Official for Tuskegee University.

A list of the current members of the TUACUC may be obtained from the Administrative

Assistant, Comparative Medicine and Resource Center (CMRC). 727-8234. the College

of Veterinary Medicine, Nursing, and Allied Health, or the Division of Research and

Sponsored Programs, Grantsmanship and Compliance website.

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Responsibilities of the TUACUC

1. Semiannual Reviews of Tuskegee University’s Animal Care Program

The PHS Policy and USDA AWR require that the TUACUC review the institution’s

program for humane care and use of animals at least once every six months using the

Guide for the Care and Use of Laboratory Animals as a basis for evaluation. This review

must include an inspection of Tuskegee University’s animal facilities, including any

satellite facilities.

2. Semiannual Reports to the Provost

Upon completion of each review, the TUACUC will submit a report to the Provost.

These reports will:

1) contain a description of the nature and extent of Tuskegee University’s adherence to

the Guide and PBS Policy;

2) identify and justify any departures from the Guide and P Polio’;

3) distinguish significant deficiencies (those that may be a threat to the health or safety

of animals) and minor deficiencies, and provide a reasonable and specific plan for

correcting each deficiency; and

4) include recommendations to the Provost regarding any aspect of Tuskegee

University’s animal care program facilities or personnel training.

Note: The responsible investigator, dean, or director must respond in writing indicating

how and when deficiencies are corrected and the steps taken to prevent future

deficiencies.

3. Reports to Office of Laboratory Animal Welfare (OLAW)

Following approval of an animal welfare assurance by OLAW, the TUACUC, through

the Provost, will submit annual reports to OLAW on or before its anniversary date. These

reports will include any changes in Tuskegee University’s animal care program,

TUACUC membership, and the addition or deletion of an animal facilities. The

TUACUC is obliged by its Assurance Number to promptly inform OLAW of any serious

or continuing noncompliance with PHS Policy, any serious deviations from provisions of

the Guide, and any suspension of an activity by the TUACUC. All reports to OLAW will

include majority and minority views filed by members of the TUACUC.

4. Reports to U.S. Department of Agriculture (USDA) Animal and Plant Health

Inspection Service (APHIS)

Tuskegee University houses animals covered under the Federal Animal Welfare Act.

Therefore, TUACUC submits annual reports, signed by the Provost, the Institutional

Official, to the USDA Animal and Plant Health Inspection Service before December 1.

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5. Review of Animal Care and Use Application Form

Any use of animals for research, teaching and testing at Tuskegee University must be

reviewed and approved by the TUACUC prior to initiating any activity related to animal

use. The faculty member or principal investigator having primary responsibility for a

project involving animals will submit to the Administrative Assistant of the Comparative

Medicine and Resource Center, a completed Animal Care and Use protocol for Research,

Teaching, Testing, or Demonstration. A copy of this application form is included

(Appendix A) and is also available at the Division of Research and Sponsored Programs

website. In reviewing the form, TUACUC will consider these important elements:

1) the rationale for the choice of species and number of animals to be used, including

evidence of consideration of ‘the three R’s (reduction in the number of animals needed,

refinement of procedures to maximize the value of the research, and replacement with

non-animal models).

2) the anticipated level of pain or discomfort to be experienced by the animals and

methods used to minimize pain or discomfort.

3) the living conditions of the animals, including housing, feeding, and non- medical

care.

4) provisions for medical care, if such care is needed.

5) knowledge demonstrated by personnel, including basic needs of the species, use of

aseptic surgical methods and procedures, proper pre- and post- surgical care, and

personnel health and safety issues.

6) the disposition of animals at the end of the project.

7) whether consideration was given to alternatives to the painful procedures.

Animals may not be acquired for use at Tuskegee University before approval is received

from the TUACUC. New application forms will be reviewed by the TUACUC during

monthly meetings.

6. Monitoring and Possible Suspension of Ongoing Activities

As part of the monthly review process, or through visits to Tuskegee University’s animal

care facilities at other times, members of the TUACUC note whether adherence to

approved protocols is being maintained. If serious problems are noted, the TUACUC may

convene to consider suspension of an activity. If the TUACTJC votes to suspend the

activity, the TUACUC Chair will meet with the responsible faculty member or principal

investigator to state the reasons for the suspension and necessary corrective actions. If the

activity is funded by PHS, a report will be forwarded to OLAW.

Ongoing activities will be reviewed by the TUACUC annually to ensure that significant

departures from approved protocols have not occurred. The TIJACUC Chair along with a

designee will meet with the investigator to review the original protocol and discuss

departures. Long-term activities will be subject to frill review by the TUACUC every

three years for OLAW and annually for USDA. A new application form is required for

this review, except for teaching protocols. The procedure for these reviews will be the

same as for initial applications.

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7. Responding to Public Concerns

TUACUC should be prepared to answer questions regarding Tuskegee University’s

animal care policy posed by members of the University community or the general public.

The TUACUC will investigate any accusations regarding violations of federal

regulations, determine whether the accusations are valid and take corrective action or

suspension of an ongoing activity if necessary, No University employee, student, or

TUACUC member will be discriminated against or be subject to any reprisal for

reporting violations of federal regulations. Procedures for reporting animal care concerns

will be posted throughout the animal facility.

8. Record Keeping

The Administrative Assistant and the Attending Veterinarian will maintain, and provide

copies of the following documents to the Office of the Provost

1) The University’s Animal Welfare Assurance Number;

2) Minutes of TUACUC meetings, including records of attendance, activities of the

committee, and committee deliberations;

3) Records of applications, proposals, and proposed significant changes in the care and

use of animals and whether TUACUC approval was given or withheld;

4) Records of semiannual TUACUC reports and recommendations (including minority

views) submitted to the Provost.

Records shall be maintained for three years. Records that relate directly to applications,

proposals, and proposed significant changes in ongoing activities reviewed and approved

by the TUACUC shall be maintained for the duration of the project and for an additional

three years following completion of the project. The records shall be accessible for

inspection and copying by authorized OLAW or USDA inspectors at reasonable times. A

copy of all the above documents will also be on file in the Office of the Director,

Comparative Medicine Resource Center.